Biovac is a proudly South African company established in 2003 as a Public Private Partnership to revive strategically-significant vaccine development and manufacturing capability in South Africa. The on-going shortage of vaccine and biological manufacturing capability on the continent drives our determination and vision to become a centre of excellence firmly rooted in Africa.
The Key Performance Areas for this position include:
- Design, planning, implementing, maintaining, improving and actively participating in the Pharmaceutical Quality System, in conjunction with operations management.
- Provide an overview of the site processes and quality standards, and collaborate with managers and staff to improve efficiencies and compliance.
- Manage Product Quality Complaints
- Promote understanding of product and processes and their variability.
- Ensure planning of activities within the Pharmaceutical Quality by providing central coordination of required plans.
- Establish a continuous improvement culture and mechanism.
- Perform internal and supplier audits
- Achieve high performance, through the Quality Management team, against the Quality Unit’s deliverables and provide the required support to other areas in the business to ensure overall company success
- Provide strategic, operational and behavioural mentoring and guidance to direct reports
- Ensure the relevant expertise and current Good Manufacturing Practices (cGMP) alignment exists within the teams.
- Ensure continuous internal and external knowledge & skills development of the unit in line with on the job, legislative and best practice requirements
- Ensure adequate service delivery to all stakeholders internally, as well as externally
- Identify activities for delegation and empower functional managers with the required levels of decision making ability to ensure smooth running of the operations.
- Ensure effective employee relations with regards to conduct and performance in accordance with the company values as well as performance culture. Ensure that people related matters are addressed in line with labour legislation, company policies and practices.
- Participate in building and reviewing the company’s short, medium and long term strategy
- Ensure a robust, holistic, timeous and adequate planning by the Quality Unit in accordance with the company’s strategic drivers and deliverables
- Ensure sufficient resource and capacity planning in order to achieve goals within the timeframes as determined and within the budget provided
- Identify key opportunities and deliverables as required by own unit/ section or by other departments for cross functional synergies/ project work and oversee implementation
- Monitor progress and learnings on-goingly to ensure adequate return on time and resources invested.
- Proactively mitigate general business as well as area f responsibility- related risks and find ways to mitigate these.
- Ensure effective and comprehensive planning of the unit/ sections’ financial forecast and budget requirements
- Instil a cost conscious culture and responsible investment in initiatives that add value to the business and fits within the financial plan and priorities
- Drive continuous improvement plans and priorities through the implementation of appropriate tools or methodologies in order to proactively manage risk, reduce wastage and to improve quality on site
- Internal practice benchmark against quality standards of industry and regulatory bodies and create awareness of GMP updates
- Maintain and updates a library of quality and industry knowledge resources (guidelines and standards).
- Research and provide expert input as requested, e.g. gap analyses, investigations
- Facilitate Regular Review of Product, Process and PQS performance
- Coordinate Management Review (Process, Product and Pharmaceutical Quality System PQS performance)
- Define and manage the implementation of Quality metrics and their tracking
- Promote the understanding of product and processes and their variability
- Perform internal and supplier audits as agreed with QA Operations.
- Participate in quality oversight forums as required: e.g. Quality Steercom
- Ensuring that planning activities within the Pharmaceutical Quality occur
- Overall management of specified QA processes: Deviations, CAPAs, Change Control, Quality Risk Assessment, including process mapping and proactive definition of Critical Process Parameters
- Manage Product Quality Complaints
- Manage the customer and regulator audits, and ensure tracking of regulatory commitments.’
- Manage the PQS document system and ensure that implementation occurs (excluding study protocols, laboratory data books and contracts).
- Manage the long-term archiving of documents and records and ensure that they are in place
Quality Management & GMP
Quality Performance in terms of:
- Building GMP Knowledge and Compliance
- Building Quality Culture
- Establishing and maintaining a state of Control
- Driving Innovation and Continuous Improvement
- Driving Quality Risk Management
- Ensuring that area of responsibility is audit ready; closing audit findings”
- Managing Deviations, Change Controls, CAPAsQuality Objectives: Drive the quality objectives.
Qualifications & Experience
· Minimum of 8 years’ experience in a vaccine / biotechnology / pharmaceutical industry or equivalent.
· Minimum of 3 years’ management experience
· Expert knowledge of industry quality standards and practices.
· Knowledge of a sterile manufacturing environment.
· Experience in having faced successfully local and international quality audits.
· Quality & regulatory compliance knowledge, i.e. MCC and WHO
· Degree/ Diploma or related qualification in Microbiology, Biotechnology, Live Science, Pharmacy or Research Methodology or equivalent
· May require some occasional off shift and/or weekend.
· National/ International travel may be required
· Own Transport
HOW TO APPLY
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress.Interested persons to kindly submit their CV’s to [email protected] by 31 June 2016 .
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business